This invention relates to equipment, systems and methods for the removal of gaseous and/or substantially gaseous material. Such material includes, but is not limited to aerosol and particle byproducts of surgical procedures and any procedures involving cutting, heating or burning, such as odors from chemicals, ultrasonic vapors, and ion dust particles. More particularly, the present invention relates to an evacuator or vacuum head for an evacuation system that efficiently removes smoke, vapor, or plumes released by chemicals or produced by the use of lasers, sonic cutting and/or cautery or other surgical techniques or instruments at a surgical site.
Heating and/or burning of tissue during surgical procedures has become commonplace. An unwanted byproduct of such heating and/or burning, however, is the smoke generated thereby. Smoke plumes can obscure the surgeon's field of vision and the odor generated is unpleasant and distracting to the entire surgical team and to the patient, if awake. Moreover, the smoke plume may contain infectious agents that present a danger to persons in the operating room, and which can leave a lingering contamination within the operating area. Chemical vapor (e.g., such as that produced by the cleaning of computer parts) is, likewise, irritating to the respiratory tract of those who inhale it and may be carcinogenic.
Smoke evacuation and filtering systems have been developed to remove smoke plumes from surgical sites and chemical vapors from the work environment. Such systems typically include a hose connected to a vacuum source or generator and a suction wand connected to the hose, that is, placed at the site where the aerosol is generated. Various filtration systems have been used in conjunction with such vacuum generators to remove odor and infectious agents. Typically, the wand and hoses of known evacuation and filtration systems have required the constant attention or activity of an attendant to hold the wand or the nozzle of the hose close to the surgical site. Another problem is that the flow of air through the hose nozzle and the suction motor are sources of excessive and unwanted noise in the operating room or at the workstation.
More recently, at least in part to address the problems with wands, smoke evacuation systems may include an end effector that can be held in place at a surgical site without the constant attention of a nurse or other attendant. At least one such evacuation system and end effector is disclosed in U.S. Pat. No. 4,921,492 (Schultz et al.), the disclosure of which patent is incorporated herein by reference. Schultz et al. disclose an end effector for removing the gaseous byproducts of laser surgery from a surgical site. The end effector includes a flexible hose and a pliable vacuum head adhesively attachable in a substantially airtight relationship around a surgical site. The vacuum head includes a generally annular plenum for drawing plumes away from the surgical site from around a 360° arc. A porous plenum support prevents the flexible plenum from collapsing in the presence of a vacuum, and diffuses the vacuum around the entire periphery of the plenum.
U.S. Pat. No. 5,015,243 (Schifano) discloses another smoke evacuator including a flexible suction head for surrounding an operative site to draw smoke and air from around a perimeter of the site as smoke is produced. In one embodiment, the suction head is a doughnut shaped tubular member including a plurality of radial openings on an interior surface of the tubular member that faces the operative site. Schifano teaches that the tubular ring member may be circular or oval, and that it need not completely surround the operative site as long as air is drawn substantially in a surrounding fashion.
Another problem faced during operations is surgical site infection. Surgical site infections account for a large number of nosocomial infections. These types of infections occur when bacteria from the operating area enters a surgical site. Surgical site infections can increase the probability of death, and can increase a patient's hospital stay and cost. An article entitled “Guideline For Prevention of Surgical Site Infection, 1999”, published in the American Journal of Infection Control, May 1999, pp.97–118 (Mangram, Alicia J. et al.), the disclosure of which article is incorporated herein by reference, presents recommendations for preventing these types of infections. The article suggests that one way to control surgical site infections is to improve operating room ventilation. The article discloses that a laminar airflow, designed to move particle-free air (which may be known as “ultraclean air” or like) over the aseptic operating site at a velocity of around 0.3–0.5 mm/second, effectively sweeps particles out of its path, and reduces surgical site infections following operations by more than 50%. Combining the laminar airflow of ultra-clean air over a surgical site with a smoke evacuation system could increase the safety and comfort for the operating room staff and the patient.
While smoke evacuation systems and end effectors of the Schultz et al. and Schifano type are well-suited for their intended purposes, there is room for improvement. For example, while the end effectors are pliable or flexible to conform to a surface to which they are attached, neither discloses a skeletal stiffening structure or frame for helping to maintain a conformed shape. Such a skeleton or frame would be valuable to adapt end effectors or vacuum heads for smoke evacuation for use on or near irregular physical features such as, for example, the ear, nose, mouth, or in the area of joints. It would also be advantageous if the generally central, site access opening of such end effectors could be selectively varied in size to accommodate different sizes of incisions and different procedures, and if end effectors could be made available with the intake opening or openings in various locations, so that a particular end effector could be selected depending on the procedure to be performed. It would be advantageous if end effectors were available in a generally elongated, tubular shape bendable into a selected configuration by the user, and wherein the shaped or bent effectors would tend to remain in the selected configuration. It would be advantageous if a blower station and vacuum station could be set up and connected to an end effector in order to create and/or supply and evacuate a laminar airflow of ultra-clean air across a surgical site, and/or to do so in conjunction with filtration. It would also be advantageous if an end effector or vacuum head could be integrated with the widely used customary surgical drapes or drape material, or incorporated into part of a workstation that would contain noxious chemical fumes.